Sarepta launched an additional Phase III trial for Elevidys after the EMA denied marketing authorization based on evidence concerns from the prior program. While the therapy received FDA approval in the US, the European regulator cited insufficient efficacy and safety data. Roche will oversee the registration-enabling study under Sarepta’s plan to address EMA’s requirements with additional placebo-controlled data over 72 weeks. The update also follows prior safety concerns acknowledged by Sarepta and Roche, including a voluntary halt tied to acute liver failure deaths in non-ambulatory patients.